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Demystifying Decentralized Clinical Trials – Contract Pharma

From an increased demand for biologic treatment to urgent vaccine development needs, the clinical trials industry has been challenged in the last few years to deliver results more quickly so life-changing treatments can get to market faster. This accelerated environment has led sponsors and contract research organizations (CROs) to develop new processes and efficiencies to expand capacity. Decentralized clinical trials — and the digitalization tools that support them — have helped meet that need.

Whether hybrid or fully virtual, the decentralized clinical trial model has pushed the boundaries of what’s possible in a remote patient setting. This is evident in the increasing growth of the clinical trials market. The global clinical trials market, which reached an estimated $44 billion in 2020, is expected to expand at a compound annual growth rate (CAGR) of 5.7% from 2021 to 2028.One In addition, it’s estimated that about 1,300 clinical trials will incorporate a decentralized and/or virtual component in 2022 — a 28% increase over 2021 and 93% higher than 2020.2 The extent of decentralization in trials taking this approach varies significantly, with most trials adopting a hybrid structure.

Understanding the advantages and disadvantages of choosing a hybrid or fully remote clinical trial can help partners throughout the workflow — from sponsors to CROs to suppliers — collaborate on clinical trials that are reliable, compliant and, most importantly, patient-focused.

Creating Opportunities With Decentralized Trials
Already emerging as a trend, the use of a decentralized approach not only accelerated during the COVID-19 pandemic, but it was also pressure-tested. As a result, we can more completely understand the full potential of designing hybrid or remote clinical trials:

Improved patient experience: Patients are at the heart of any clinical trial. Creating the best possible experience starts with building a clinical trial around their needs and preferences, including their comfort level with any technology the clinical trial might use, such as wearable devices, apps or telemedicine.

The use of these technologies eliminates the need for patients to spend time visiting clinical trial sites, minimizing participation barriers. With a decentralized approach, CROs use various types of technology to communicate with and collect data directly from the patients, often in real time.

Expanded patient diversity: By not choosing a traditional site-centered clinical trial model, sponsors and CROs can expand past the geographical boundaries that limit access to specific patient populations. For example, decentralization provides a path to diverse populations in emerging regions, including what’s often called the BRICS block (Brazil, Russia, India, China and South Africa) and the Middle East. The model also enables CROs to recruit patients who are geographically remote patients, are underrepresented ethnic minorities or have barriers to traditional trial participation, like limited access to travel. The result is a more diverse data set that supports the study’s validity.

Better recruitment and retention: With a full suite of digital tools — from social media to e-health records to telemedicine — and the ability to go beyond traditional geographic boundaries, decentralized clinical trials can help engage potential patients and retain them once the study begins. For example, in a Type 1 diabetes clinical trial, researchers used social media to recruit college students and achieved an 88.4% retention rate. Digital tools can also support trials in other age groups as well.3 A blood pressure clinical trial in middle-aged and older patients significantly increased recruited participants from 1.8 per month with conventional recruitment methods to 7.3 per month with Facebook recruitment.4

Meeting Challenges To Create Opportunities
Decentralized clinical trials offer sponsors and CROs significant advantages, yet there are challenges that are essential to consider. To maintain operational efficiency and avoid delays, consider these challenges during the planning stage:

Navigating regulatory compliance: While clinical trial sponsors and CROs are well accustomed to working in a heavily regulated environment, the decentralized model presents additional compliance challenges. Regulatory frameworks are evolving to address the use of clinical trial technology. For example, only some brands of consumer smart watches will align with relevant regulatory standards.

Increasing expectations for a consumerlike experience: The “Amazon effect,” or the ability to have visibility into exactly where an item is in the supply chain, has changed expectations across the entire workflow for a more consumerlike experience. In a decentralized clinical trial, every stakeholder, from clinical staff to patients, wants to know where clinical trial kits, samples and equipment are and when they will arrive.

Managing the complexity of logistics: Along with shifting expectations for supply chain visibility, decentralized trials demand robust, flexible logistics that ensure supply chain integrity. For example, instead of shipping clinical trial kits to several central sites, CROs must now manage shipping to hundreds or thousands of individual patients’ homes. Additional complexity is added when factoring in the wide range of logistics-related technology, from scannable labels that track a sample across the workflow to machine learning tools that anticipate capacity or hours of service.

The key to overcoming the challenges in decentralized clinical trials is to select and work collaboratively with experienced partners able to navigate every aspect of the workflow. These partnerships are essential to ensuring reliable, compliant and patient-centric trials that move life-changing treatments from discovery to delivery faster.

4 Best Practices for Technology Integration

1. Streamline the patient experience.
Creating a good patient experience is at the heart of every clinical trial design — and that doesn’t change when we bring the trial to the patient. Patient-facing technology is only as effective as your patients’ ability to use it. Make sure that devices and other technology are easy to understand and convenient to use.

2. Plan data management across the entire trial workflow.
Every partner in the clinical trial workflow has a responsibility to support data management with front-end and back-end integration across the clinical trials workflow. From patient recruitment to long-term storage, establishing clear data ownership at every step of the clinical workflow is essential support for the sponsor if there are questions at approval submission.

3. Define and build for reliable data.
Build a robust data ecosystem by asking from the onset: What’s the right data set and data detail required for our protocol? Wearable and other technology — in particular those that offer continuous monitoring — can inundate investigators with data. Any data that’s not essential to the protocol must still be managed and analyzed, adding to time, cost and complexity.

4. Understand the evolving regulatory framework for technology.
From wearable medical devices to cybersecurity to data privacy, it’s essential to understand all relevant regulations for every region where the clinical trial is conducted. As countries evolve their regulations, it’s important to work with local experts familiar with each region to ensure the clinical trial’s technology stays in good regulatory standing.

References:

4. Nash EL et al. Facebook advertising for participant recruitment into a blood pressure clinical trial: https://pubmed.ncbi.nlm.nih.gov/28704263/


Claudia Berrón is Avantor’s Senior Vice President, Clinical Services. Claudia has over two decades of experience in B2B strategic marketing covering ideation, value proposition strategies, market segmentation, marketing and sales planning through product launch, and has been working with Avantor since 2015. She holds an MBA from the University of North Carolina Kenan- Flagler Business School in Chapel Hill, North Carolina, and a bachelor’s degree from Monterrey Institute of Technology in Mexico City.

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